Senior Clinical Research Specialist

3 weeks ago


Reston, Virginia, United States Kelly Science, Engineering, Technology & Telecom Full time

Job Title: Senior Clinical Research Specialist

Kelly Science, Engineering, Technology & Telecom is seeking a highly skilled Senior Clinical Research Specialist to join our team. As a key member of our Clinical R&D Department, you will be responsible for supporting the execution of company-sponsored clinical trials, ensuring compliance with timelines and study milestones.

Key Responsibilities:

  • Serve as a Senior Clinical Research Specialist to support the execution of clinical trials, ensuring compliance with timelines and study milestones.
  • Oversight/execution of feasibility, selection, set up, conduct, and closure of clinical trials within allocated countries, in accordance with ICH-GCP, applicable legislation, and Company Standard Operating Procedures.
  • Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
  • Responsible for clinical data review to prepare data for statistical analyses and publications.
  • May perform monitoring activities, including site qualification visits, site initiation visits, interim monitoring visits, or close-out visits, based on study need.

Requirements:

  • Minimum of a Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science.
  • BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.
  • Previous experience in clinical research or equivalent required.
  • Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

Location and Travel Requirements:

Primary location for this position is Irvine. At management discretion, the position may be performed remotely. Ability to travel approximately 20% depending on the phase of the program.

External Interactions:

Frequent interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated. May have regular interaction with third-party vendors supporting clinical studies as applicable per program.



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